Chelsea’s Data on Fainting Drug Is Inadequate, FDA Says

Jan. 10 (Bloomberg) -- Chelsea Therapeutics International
Ltd.’s new data on its drug for preventing sudden drops in blood
pressure falls short of what’s needed for approval, U.S.
regulators said. The company sank the most in 13 months on the
setback to its effort to bring its first treatment to market.

The data doesn’t answer questions the Food and Drug
Administration posed about the efficacy of the medicine called
Northera, agency staff said in a report posted today. FDA
advisers plan to meet Jan. 14 to weigh approval of the therapy.

The FDA rejected Northera in March 2012, sending the
company what’s known as a complete response letter, and asked
for an additional study to ensure the drug works over an
extended period of time. Chelsea resubmitted the medicine for
FDA review in July and the FDA is expected to decide whether to
approve Northera by Feb. 14.

“This reviewer recommends a Complete Response action for
droxidopa in the treatment of symptomatic neurogenic orthostatic
hypotension (NOH), because of inadequate evidence of
effectiveness,” Shari Targum at the FDA wrote in the most-recent review dated December 2013 in the report.

Chelsea fell 29 percent to $2.50 at the close in New York,
in its biggest single-day drop since December 2012. The
Charlotte, North Carolina-based company has more than doubled in
the past 12 months.

300,000 People

The blood pressure drop is known as neurogenic orthostatic
hypotension, which is common in the elderly and people with
disorders such as Parkinson’s disease. Chelsea Therapeutics
estimates almost 300,000 people suffer from the condition
chronically in the U.S. and EU.

Targum’s review questioned whether the new data proved the
drug worked better than a placebo after one week, the same issue
FDA workers raised when Chelsea first sought Northera approval.
A 2012 review that doesn’t consider the new data from FDA’s
Melanie Blank makes five arguments in favor of clearing the drug
for sale and seven arguments against, including the lack of
durable effect.

FDA workers raised concern before the 2012 advisory panel
meeting that Northera may also be linked to a life-threatening
neurological disorder based on unsubstantiated reports of the
condition associated with the drug’s use in Japan, where it’s
available as part of a marketing agreement with Dainippon
Sumitomo Pharma Co. While new data didn’t reveal any clearly
defined cases of the disorder, Chelsea’s database may not be
large enough to exclude such a rare side effect, FDA’s Targum
wrote.